ISO 13485

Can your scientific device corporation byskip a marvel audit? If you said “Of course, we can!” you then definitely absolutely`d be withinside the minority.

An ultra-modern survey showed that the best 38% of scientific device professionals were “very confident” they’ll byskip a marvel audit.

So if you’re part of that underconfident 62%, then it’s time to make a change.

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Creating a culture it’s miles targeted spherical first-rate can hold you audit-geared up 24/7/365 and give you a competitive advantage that can help you win your market.

We’ve reviewed the exceptional ISO 13485 hollow assessment templates to help you pick out the right one so that you can gauge your corporation’s first-rate practices vs. the favored ones. Once you’ve got diagnosed the gaps, you could begin to close them and make considerable improvements in your corporation.

The Pros and Cons of the 4 Best ISO 13485 Gap Analysis Templates

ISO 13485:2016 is the worldwide favored for Quality Management Systems (QMS) used by companies involved withinside the manufacturing, servicing, distribution, and disposal of scientific devices.

If you hold an ISO 13485:2016 certification, you then definitely absolutely are recognized as being able to manufacture scientific devices that meet or exceed organization necessities.

Holding this certification can help open new markets in your industrial organization and assemble keep in mind collectively at the side of your customers.

A hollow assessment can help your first-rate managers determine if your QMS is absolutely aligned with the ISO 13485:2016 favored. After you whole the assessment, you want to apprehend how geared up you are to (hopefully) byskip a third-birthday birthday party ISO certification audit.

What ISO 13485 hollow assessment template want to you use? Here are some of the top options withinside the marketplace.

1. The 13485 Store


  • The 60-net web page checklist covers every section of an ISO 13485 Medical Device Quality Management System.
  • It is provided in Microsoft Word format to make improvement smooth.
  • It is composed of steering on what to look for to evaluate your contemporary-day procedures and compliance.
  • The checklist has regions for non-public notes.
  • The template links to more assisting information for certain clauses.
  • It stipulates that six approaches are required and they are highlighted in yellow in this checklist.


  • It’s now not free – but it does consist of the technical manual in your purchase.


  • The price for the checklist is $39, and it could be sold.

2. Safety Culture


  • There are checklist template builders available — ISO 13485 Audit Checklist and ISO 13485 Standards Checklist.
  • The template editor is interactive and smooth to use.
  • Both checklists are available freed from rate.
  • The necessities checklist is conveniently divided into five sections that follow ISO 13485 key clauses.
  • The necessities checklist will help you pick out “done,” “in progress,” “now not started,” and “now not applicable” for various sections.


  • You can best use this checklist if you create a free iAuditor account.
  • You will use your mobileular device and iAuditor App to conduct your audit.


Both checklists can be downloaded freed from the rate.

RELATED READING: An ISO 13485 Risk Management Plan Example You Can Steal and Use

3. 13485 Academy 


  • It’s particularly smooth to complete with smooth certain and no answers.
  • You can shop your progress, so you do now no longer have to complete it all in one sitting.
  • Sections 4, 5, 6, 7, and 8 are all covered.


  • The checklist is best available on their net web website online.
  • There’s no more clarification or documentation for the sections and questions.


This checklist is provided on the Adviser net web website online freed from rate.

4. Praxiom


  • At 99 pages long, that could be an absolutely entire template.
  • They provide a free sample of most of section 7, so you can see how precise it’s far in advance than shopping for the general checklist.
  • Both a PDF and MS Word version are provided.


  • It says that it’s miles smooth to understand, but based totally mostly on what the free sample shows, that looks questionable.
  • They say to use this checklist to develop a first-rate manipulate compliance plan, but, they do now no longer seem to provide any more assistance in studying your consequences.


The sample assessment tool can be downloaded freed from rate while the general version is available for purchase for $175. You can find more information and links to every sample and paid version.

Quality Score — For When You Need More Than Templates

You need a gap assessment template in a very good manner to wreck the ISO 13485:2016 recommendations down enough for you a good way to definitely look into your procedures properly. There’s a diploma of detail that you need to have in your templates in advance its miles actually properly really well worth your time.

Templates and checklists are awesome for identifying if you have a problem, but they cannot help you clear up it.

As the provider of the exceptional ISO 13485 QMS software program software for startups and scale-ups, we understand that you need every tool and real human manual to adopt a culture of first-rate in your corporation. (You can examine more about our solution here.)

So if you’re essentially about putting first-rate first, then let’s get started.

Step #1: Use our free self-assessment Quality Score tool — it’s miles best 20 questions, and you could whole it in 5 minutes or less.

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Our self-assessment will help you short see the manner you stack up closer to exceptional practices and give you some actionable and unique tactics that you could decorate your first-rate manipulation.

Step #2: Take advantage of the free consultation at the end.

When you whole the assessment, you’ll be provided a free consultation to speak approximately your consequences. We extraordinarily advocate that you take advantage of that opportunity to have a live talk with an expert from our team.

Our expert may be capin a function to help you understand your consequences and develop a plan for reinforcing first-rate in your corporation.


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